Leaflet: information for the user

bicalutamide cinfa 50 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

bicalutamide cinfabelongs to a group of medications called anti-androgens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medication is used in the treatment of advanced prostate cancer(daily dose of 50 mg)in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or concurrently with surgical removal of the testicles.

It is also used in the treatment of prostate cancer without metastasis, in cases where there is a high risk of progression of the disease (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiation therapy.

Do not takebicalutamida cinfa

• If you are allergic to bicalutamida or any of the other components of this medication (listed in section 6).
• If you are a woman.
• If you are taking terfenadina or astemizol, which are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

Bicalutamida should not be administered to children and adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamida cinfa:

• If you have any liver disorder or disease that affects your liver. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests. Severe liver changes and liver failure have been reported.
• If you have a lung inflammation called interstitial lung disease. The symptoms of this condition may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you are taking any medication, including those obtained without a prescription. In particular, if you are taking medications that thin the blood or medications to prevent blood clotting.
• If you have diabetes. The combined treatment of bicalutamida with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dose.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamida in these cases.
• If you are taking a daily dose of 150 mg of bicalutamida and have a heart disease. Your doctor may choose to check your heart function periodically.

Inform your doctor if you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamida is used.

If any of the above situations apply to you, inform your doctor, who will take this into account during your treatment with bicalutamida.

Inform hospital staff that you are taking bicalutamida.

If you are taking bicalutamida, you and/or your partner should use a contraceptive method while you are on treatment with bicalutamida and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents

Bicalutamida should not be administered to children and adolescents under 18 years old.

Other medications and bicalutamida cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those obtained without a prescription and herbal remedies.

Do not take bicalutamida with the following medications:

• Terfenadina or astemizol (for hay fever or allergy).
• Cisaprida (for stomach disturbances).

If you takebicalutamidawith any of the following medications, the effect of this and the other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamida:

• In particular, inform your doctor if you are taking blood-thinning medications such as warfarina.
• Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).
• Cimetidina (to treat stomach ulcers).
• Ketoconazol (used to treat fungal infections of the skin and nails).

Bicalutamida may interfere with some medications used to treat heart rhythm problems (e.g., quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

Please note that these warnings may also apply to medications you have used in the past.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Bicalutamida should not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamida may have an effect on male fertility that may be reversible.

Driving and operating machinery

Bicalutamida may make you feel drowsy, so you should be careful when driving or operating machinery.

bicalutamida cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

bicalutamida cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• In adults, the recommended dose is 1 tablet per day (equivalent to 50 mg of bicalutamide) or 3 tablets per day (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with water.
• Try to take the tablet(s) at the same time every day.

In patients with prostate cancer without metastasis who have a high risk of disease progression, the recommended dose is 3 tablets per day (equivalent to 150 mg of bicalutamide).

If you take more Bicalutamide Cinfa than you should

If you ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Bicalutamide Cinfa

Do not take a double dose to compensate for the missed doses, simply continue with your usual treatment.

If you interrupt treatment with Bicalutamide Cinfa

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects,although not everyone will experience them.

If you notice any of the following symptoms,inform your doctor immediately or go to the nearest hospital emergency department. These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling, or the formation of blisters or scabs.
• Swelling of the face or neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellow discoloration of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

Very common (may affect more than 1 in 10 patients):

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (urge to vomit).
• Confusion.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common (may affect up to 1 in 10 patients):

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellow discoloration of skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

Uncommon (may affect up to 1 in 100 patients):

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

Rare (may affect up to 1 in 1,000 patients):

• Liver failure. Fatalities have been reported.
• Increased sensitivity to sunlight.

Frequency not known (cannot be estimated from available data):

• Changes in the electrocardiogram ECG (prolongation of the QT interval).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of bicalutamida cinfa

• The active ingredient is bicalutamida. Each tablet contains 50 mg of bicalutamida.
• The other components are:

Tablet core: lactose monohydrate, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate, and purified water.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, and purified water.

Appearance of the product and contents of the packaging

bicalutamida cinfa is presented in the form of coated tablets with a film coating, white in color, cylindrical, and biconvex. One of the faces is engraved with “BCM 50”.

Each package contains 30 or 100 (clinical package) tablets, packaged in PVC/PE/PVDC/Aluminum blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

SYNTHON BV Microweg,

22, P.O.Box 7071 (Nijmegen) - NL-6545 - Netherlands

Synthon Hispania S.L.

Castelló, 1 Polígono Las Salinas 08830 Sant Boi de Llobregat Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: May 2021

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68818/P_68818.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68818/P_68818.html